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OpenTrials
Completed

NCT Number: NCT01648972

Gastrografin in Postoperative Ileus

After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital.

The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.

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Key information

Conditions

Prolonged Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Auckland City Hospital

Auckland, AKL, 1010, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Current inpatient following elective laparoscopic or open surgery.
  • Classified as having prolonged postoperative ileus.
  • Able to understand risks/benefits of the study.
  • Able to give informed consent.

Exclusion criteria

  • Pregnancy.
  • ASA of 4 or greater.
  • Previous allergic reaction to gastrografin or iodinated contrast agents.
  • Manifest hyperthyroidism.

Treatment and study plan

Gastrografin

Drug

Placebo

Drug

Primary outcomes

  1. Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.

Secondary outcomes

  1. Length of hospital stay (days)

    Time frame: Days

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Official study title

Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.

Acronym: GAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2012
Registry last updated
Jul 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.